The Use of Steri3X for Prevention of Post-operative Wound Infections in

Status Not yet recruiting

Clinical Trial Summary

Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.

Clinical Trial Description

Postpartum infection is a major cause of maternal morbidity and prolonged hospitalization, and places a large burden on the healthcare system with an additional cost of $3,700 (Olsen et al., 2010). Surgical site infection (SSI) is one of the most common post-operative complications following cesarean section, with an incidence of 3-15% worldwide (Zuarez-Eaaston et al., 2017). Wound dressings that are applied after closure of a surgical incision may help healing by providing physical support, protection from external contaminants, and by absorbing exudate (Dumville et al., 2016). A new FDA-approved microbicidial liquid adhesive, Steri3X, has been shown to reduce the incidence of pin-tract infection by 100% in a randomized-controlled trial following external fixation in patients undergoing reconstructive surgery for deformity correction (Pema, 2020). Steri3X is reported to be effective against S. aureus (both MSSA and MRSA), Candida albicans, E. coli, P. aeruginosa, and Candida auris, which are common organisms involved in dermatological infections. The most common organisms responsible for cesarean section SSI include enteric gram negative bacilli, enterococci, and group B streptococcus (Gur et al., 2015). The advantage of this polymer following C-sections is unknown, and a larger study is needed to provide a more robust analysis. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05392400
Study type	Interventional
Source	University of Tennessee
Contact	Bethany Erickson, MD
Phone	7012268304
Email	bericks5@uthsc.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	February 7, 2023
Completion date	February 7, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04096885` - The Inselspital Surgical Cohort Study
Terminated	`NCT03820648` - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy	N/A
Completed	`NCT04067843` - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study	N/A
Terminated	`NCT04042077` - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections	Phase 3
Completed	`NCT05841576` - Anaesthetic Management Guided by COMET Measurements	N/A
Withdrawn	`NCT05338281` - NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT	N/A
Recruiting	`NCT03042091` - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery	Early Phase 1
Completed	`NCT01697748` - Prospective Study on Cesarean Wound Outcomes	N/A
Terminated	`NCT01789697` - Text Message Study	N/A
Recruiting	`NCT05966961` - Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Recruiting	`NCT05077592` - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections	Phase 4
Recruiting	`NCT05763602` - PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)	Phase 4
Recruiting	`NCT05502380` - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery	Phase 3
Recruiting	`NCT03221023` - Intrawound Vancomycin Prophylaxis for Neural Stimulator	Phase 2/Phase 3
Completed	`NCT03257202` - Topical Treatment and Prevalence of P. Acnes	Phase 2
Completed	`NCT06154720` - Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Not yet recruiting	`NCT06465901` - A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI	N/A
Not yet recruiting	`NCT04820075` - Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery	N/A
Recruiting	`NCT03561376` - Zinc Oxide Versus Petrolatum Following Skin Surgery	Early Phase 1
Not yet recruiting	`NCT04496180` - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms